Presbyopia
Conditions
Keywords
Nyxol, Presbyopia, Pilocarpine
Brief summary
The objectives of this study are: To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia
Interventions
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
DRUGPilocarpine
Pilocarpine ophthalmic solution
OTHERPlacebo
Topical sterile ophthalmic solution
Sponsors
Ocuphire Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females ≥ 40 and ≤ 64years of age. 2. BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions. 3. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly. 4. Subjects who depend on reading glasses or bifocals in which their binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.
Exclusion criteria
Ophthalmic (in either eye): 1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion. 2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening until study completion. 3. Current use of any topical ophthalmic therapy for dry eye. 4. Tear break-up time of \< 5 seconds or corneal fluorescein staining. 5. Clinically significant ocular disease that might interfere with the study as deemed by the Investigator. 6. Recent or current evidence of ocular infection or inflammation in either eye. 7. Any history of herpes simplex or herpes zoster keratitis. 8. History of diabetic retinopathy or diabetic macular edema. 9. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations. 10. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal. 11. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded. 12. History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris. 13. Unwilling or unable to discontinue use of contact lenses. 14. Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale. Systemic: 15. Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists. 16. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents. 17. Clinically significant systemic disease that might interfere with the study as deemed by the Investigator. 18. Participation in any investigational study within 30 days prior to Screening. 19. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. 20. Resting HR outside the specified range of 50 to 110 beats per minute. 21. Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | Visit 2 at 1 hour | The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours | The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours |
| Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline | Visit 2 at 1 hour | The percentage of subjects with improvement of ≥ 15 letters in DCNVA (photopic) at 1 hour and with \< 5 letters of loss in photopic binocular BCDVA from Baseline |
| Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | Visit 2 at 1 hour, at 3 hours, and at 6 hours | The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| POS 0.75% First, Then LDP 0.4% Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.
Then, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.
Treatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. | 43 |
| POS 0.75% First, Then LDP Vehicle Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.
Then, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.
Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.
Treatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. | 30 |
| POS Vehicle First, Then LDP 0.4% Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.
Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine: 0.4% Pilocarpine ophthalmic solution, a direct-acting cholinergic agonist at Visit 2.
Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.
Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (0.4% LDP) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. | 31 |
| POS Vehicle First, Then LDP Vehicle Participants received Phentolamine Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.
Then, after 3-4 days of initial administration of POS Vehicle, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.
Treatment 1 (POS Vehicle) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments. | 44 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | POS Vehicle First, Then LDP 0.4% | Total | POS 0.75% First, Then LDP Vehicle | POS 0.75% First, Then LDP 0.4% | POS Vehicle First, Then LDP Vehicle |
|---|---|---|---|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 5.21 | 53.1 years STANDARD_DEVIATION 5.09 | 52.8 years STANDARD_DEVIATION 5.11 | 53.4 years STANDARD_DEVIATION 5.63 | 53.2 years STANDARD_DEVIATION 4.55 |
| Baseline IOP fellow eye | 14.1 mmHg STANDARD_DEVIATION 2.41 | 14.3 mmHg STANDARD_DEVIATION 2.83 | 14.9 mmHg STANDARD_DEVIATION 2.94 | 14.3 mmHg STANDARD_DEVIATION 2.99 | 13.8 mmHg STANDARD_DEVIATION 2.85 |
| Baseline IOP study eye | 13.9 mmHg STANDARD_DEVIATION 2.54 | 14.1 mmHg STANDARD_DEVIATION 3.03 | 14.8 mmHg STANDARD_DEVIATION 3.14 | 14.4 mmHg STANDARD_DEVIATION 3.4 | 13.6 mmHg STANDARD_DEVIATION 2.88 |
| Baseline mesopic BCDVA binocular | 52.6 letters read at 4 m distance STANDARD_DEVIATION 5.44 | 54.0 letters read at 4 m distance STANDARD_DEVIATION 4.68 | 54.2 letters read at 4 m distance STANDARD_DEVIATION 4.93 | 54.1 letters read at 4 m distance STANDARD_DEVIATION 3.31 | 54.8 letters read at 4 m distance STANDARD_DEVIATION 4.98 |
| Baseline mesopic BCDVA fellow eye | 50.2 letters read at 4 m distance STANDARD_DEVIATION 6.14 | 51.2 letters read at 4 m distance STANDARD_DEVIATION 5.38 | 50.6 letters read at 4 m distance STANDARD_DEVIATION 6.53 | 51.3 letters read at 4 m distance STANDARD_DEVIATION 4.11 | 52.2 letters read at 4 m distance STANDARD_DEVIATION 5.06 |
| Baseline mesopic BCDVA study eye | 50.6 letters read at 4 m distance STANDARD_DEVIATION 5.83 | 51.0 letters read at 4 m distance STANDARD_DEVIATION 5.36 | 49.5 letters read at 4 m distance STANDARD_DEVIATION 6.44 | 51.0 letters read at 4 m distance STANDARD_DEVIATION 3.95 | 52.2 letters read at 4 m distance STANDARD_DEVIATION 5.31 |
| Baseline mesopic DCNVA binocular | 40.1 letters read at 4 m distance STANDARD_DEVIATION 6.41 | 40.6 letters read at 4 m distance STANDARD_DEVIATION 6.13 | 40.4 letters read at 4 m distance STANDARD_DEVIATION 6.36 | 41.4 letters read at 4 m distance STANDARD_DEVIATION 5.99 | 40.3 letters read at 4 m distance STANDARD_DEVIATION 6.05 |
| Baseline mesopic DCNVA fellow eye | 38.1 letters read at 4 m distance STANDARD_DEVIATION 6.35 | 37.7 letters read at 4 m distance STANDARD_DEVIATION 6.59 | 37.3 letters read at 4 m distance STANDARD_DEVIATION 6.92 | 38.2 letters read at 4 m distance STANDARD_DEVIATION 6.59 | 37.3 letters read at 4 m distance STANDARD_DEVIATION 6.7 |
| Baseline mesopic DCNVA study eye | 37.3 letters read at 4 m distance STANDARD_DEVIATION 6.54 | 36.2 letters read at 4 m distance STANDARD_DEVIATION 6.71 | 34.6 letters read at 4 m distance STANDARD_DEVIATION 6.81 | 36.2 letters read at 4 m distance STANDARD_DEVIATION 7.05 | 36.4 letters read at 4 m distance STANDARD_DEVIATION 6.45 |
| Baseline mesopic PD fellow eye | 4.996 mm STANDARD_DEVIATION 1.1266 | 5.117 mm STANDARD_DEVIATION 0.8789 | 5.100 mm STANDARD_DEVIATION 0.6839 | 5.136 mm STANDARD_DEVIATION 0.8759 | 5.197 mm STANDARD_DEVIATION 0.8201 |
| Baseline mesopic PD study eye | 4.992 mm STANDARD_DEVIATION 1.153 | 5.059 mm STANDARD_DEVIATION 0.8942 | 5.049 mm STANDARD_DEVIATION 0.7324 | 5.059 mm STANDARD_DEVIATION 0.8747 | 5.113 mm STANDARD_DEVIATION 0.831 |
| Baseline photopic BCDVA binocular | 60.0 letters read at 4 m distance STANDARD_DEVIATION 3.77 | 60.9 letters read at 4 m distance STANDARD_DEVIATION 3.45 | 61.2 letters read at 4 m distance STANDARD_DEVIATION 3.53 | 61.0 letters read at 4 m distance STANDARD_DEVIATION 2.97 | 61.4 letters read at 4 m distance STANDARD_DEVIATION 3.56 |
| Baseline photopic BCDVA fellow eye | 57.7 letters read at 4 m distance STANDARD_DEVIATION 3.29 | 58.7 letters read at 4 m distance STANDARD_DEVIATION 3.4 | 58.9 letters read at 4 m distance STANDARD_DEVIATION 3.39 | 58.5 letters read at 4 m distance STANDARD_DEVIATION 3.12 | 59.3 letters read at 4 m distance STANDARD_DEVIATION 3.69 |
| Baseline photopic BCDVA study eye, letters read | 58.1 letters read at 4 m distance STANDARD_DEVIATION 3 | 58.3 letters read at 4 m distance STANDARD_DEVIATION 3.31 | 57.9 letters read at 4 m distance STANDARD_DEVIATION 2.84 | 57.8 letters read at 4 m distance STANDARD_DEVIATION 3.46 | 59.2 letters read at 4 m distance STANDARD_DEVIATION 3.58 |
| Baseline photopic DCIVA binocular | 50.9 letters read STANDARD_DEVIATION 4.87 | 51.5 letters read STANDARD_DEVIATION 6.24 | 52.6 letters read STANDARD_DEVIATION 7.45 | 51.3 letters read STANDARD_DEVIATION 6.42 | 51.5 letters read STANDARD_DEVIATION 6.14 |
| Baseline photopic DCIVA fellow eye | 48.4 letters read STANDARD_DEVIATION 5.1 | 48.6 letters read STANDARD_DEVIATION 6.25 | 49.1 letters read STANDARD_DEVIATION 7.01 | 48.7 letters read STANDARD_DEVIATION 6.68 | 48.3 letters read STANDARD_DEVIATION 6.19 |
| Baseline photopic DCIVA study eye | 46.9 letters read STANDARD_DEVIATION 6.34 | 46.5 letters read STANDARD_DEVIATION 6.86 | 45.3 letters read STANDARD_DEVIATION 8.04 | 47.4 letters read STANDARD_DEVIATION 6.87 | 46.0 letters read STANDARD_DEVIATION 6.39 |
| Baseline photopic DCNVA binocular | 47.6 letters read at 4 m distance STANDARD_DEVIATION 3.49 | 46.3 letters read at 4 m distance STANDARD_DEVIATION 4.15 | 45.3 letters read at 4 m distance STANDARD_DEVIATION 5.32 | 46.3 letters read at 4 m distance STANDARD_DEVIATION 3.85 | 46.1 letters read at 4 m distance STANDARD_DEVIATION 3.83 |
| Baseline photopic DCNVA fellow eye | 44.7 letters read at 4 m distance STANDARD_DEVIATION 4.61 | 44.3 letters read at 4 m distance STANDARD_DEVIATION 4.95 | 42.8 letters read at 4 m distance STANDARD_DEVIATION 6.28 | 44.5 letters read at 4 m distance STANDARD_DEVIATION 4.48 | 44.9 letters read at 4 m distance STANDARD_DEVIATION 4.56 |
| Baseline photopic DCNVA study eye | 42.8 letters read at 4 m distance STANDARD_DEVIATION 5.34 | 41.3 letters read at 4 m distance STANDARD_DEVIATION 5.9 | 37.9 letters read at 4 m distance STANDARD_DEVIATION 7.23 | 41.8 letters read at 4 m distance STANDARD_DEVIATION 5.39 | 42.0 letters read at 4 m distance STANDARD_DEVIATION 5 |
| Baseline photopic PD fellow eye | 4.391 mm STANDARD_DEVIATION 0.9617 | 4.384 mm STANDARD_DEVIATION 0.8731 | 4.608 mm STANDARD_DEVIATION 0.9048 | 4.267 mm STANDARD_DEVIATION 0.8277 | 4.340 mm STANDARD_DEVIATION 0.8299 |
| Baseline photopic PD study eye | 4.342 mm STANDARD_DEVIATION 0.9966 | 4.337 mm STANDARD_DEVIATION 0.8756 | 4.494 mm STANDARD_DEVIATION 0.819 | 4.297 mm STANDARD_DEVIATION 0.8347 | 4.265 mm STANDARD_DEVIATION 0.8782 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 10 Participants | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 138 Participants | 27 Participants | 42 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Irides type, n (%) Dark | 12 Participants | 60 Participants | 12 Participants | 18 Participants | 18 Participants |
| Irides type, n (%) Light | 19 Participants | 88 Participants | 18 Participants | 25 Participants | 26 Participants |
| Iris color, n (%) Blue with peripupillary brown | 7 Participants | 35 Participants | 5 Participants | 14 Participants | 9 Participants |
| Iris color, n (%) Brown | 5 Participants | 31 Participants | 6 Participants | 7 Participants | 13 Participants |
| Iris color, n (%) Brown with some peripheral green | 5 Participants | 14 Participants | 2 Participants | 3 Participants | 4 Participants |
| Iris color, n (%) Central brown and peripheral green | 2 Participants | 15 Participants | 4 Participants | 8 Participants | 1 Participants |
| Iris color, n (%) Dark blue | 2 Participants | 7 Participants | 2 Participants | 0 Participants | 3 Participants |
| Iris color, n (%) Green with brown iris ring | 4 Participants | 17 Participants | 4 Participants | 5 Participants | 4 Participants |
| Iris color, n (%) Light blue | 3 Participants | 20 Participants | 6 Participants | 5 Participants | 6 Participants |
| Iris color, n (%) Uniform green | 3 Participants | 9 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 11 Participants | 3 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 132 Participants | 26 Participants | 40 Participants | 38 Participants |
| Sex: Female, Male Female | 18 Participants | 108 Participants | 23 Participants | 38 Participants | 29 Participants |
| Sex: Female, Male Male | 13 Participants | 40 Participants | 7 Participants | 5 Participants | 15 Participants |
| Study eye, n (%) OD | 23 Participants | 110 Participants | 23 Participants | 29 Participants | 35 Participants |
| Study eye, n (%) OS | 8 Participants | 38 Participants | 7 Participants | 14 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 30 | 0 / 31 | 0 / 45 |
| other Total, other adverse events | 15 / 44 | 6 / 30 | 6 / 31 | 2 / 45 |
| serious Total, serious adverse events | 0 / 44 | 0 / 30 | 0 / 31 | 0 / 45 |
Outcome results
Primary
Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA
The primary efficacy endpoint was the percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA on Visit 2 at 1 hour with POS + LDP compared to placebo alone. The improvement in binocular DCNVA for each subject was relative to the subject's own baseline value (Visit 1).
Time frame: Visit 2 at 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POS 0.75% First, Then LDP 0.4% | Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | 60.5 percentage of subjects with ≥ 15 letters |
| POS 0.75% First, Then LDP Vehicle | Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | 30.0 percentage of subjects with ≥ 15 letters |
| POS Vehicle First, Then LDP 0.4% | Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | 45.2 percentage of subjects with ≥ 15 letters |
| POS Vehicle First, Then LDP Vehicle | Percent of Subjects With ≥ 15 Letters of Improvement in Photopic Binocular DCNVA | 27.3 percentage of subjects with ≥ 15 letters |
Secondary
Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline
The percentage of subjects with improvement in DCIVA (photopic) from Baseline of ≥ 5, ≥ 10, and ≥ 15 letters
Time frame: Visit 2 at 1 hour, at 3 hours, and at 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 6 hours | 72.1 percentage with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 3 hours | 18.6 percentage with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 6 hours | 14.0 percentage with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 3 hours | 69.8 percentage with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 1 hour | 14.0 percentage with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 1 hour | 48.8 percentage with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 6 hours | 30.2 percentage with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 3 hours | 41.9 percentage with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 1 hour | 86.0 percentage with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 3 hours | 30.0 percentage with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 6 hours | 56.7 percentage with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 3 hours | 10.0 percentage with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 1 hour | 23.3 percentage with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 1 hour | 46.7 percentage with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 1 hour | 10.0 percentage with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 6 hours | 10.0 percentage with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 6 hours | 16.7 percentage with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 3 hours | 43.3 percentage with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 3 hours | 41.9 percentage with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 1 hour | 71.0 percentage with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 1 hour | 45.2 percentage with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 1 hour | 22.6 percentage with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 3 hours | 67.7 percentage with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 3 hours | 22.6 percentage with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 6 hours | 38.7 percentage with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 6 hours | 29.0 percentage with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 6 hours | 12.9 percentage with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 6 hours | 47.7 percentage with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 3 hours | 50.0 percentage with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 1 hour | 4.5 percentage with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 6 hours | 4.5 percentage with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 6 hours | 18.2 percentage with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 1 hour | 25.0 percentage with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 3 hours | 4.5 percentage with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 3 hours | 25.0 percentage with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement in DCIVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 1 hour | 56.8 percentage with improvement |
Secondary
Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline
The percentage of subjects with improvement of ≥ 15 letters in DCNVA (photopic) at 1 hour and with \< 5 letters of loss in photopic binocular BCDVA from Baseline
Time frame: Visit 2 at 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline | 60.5 % of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline | 30.0 % of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline | 41.9 % of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 15 Letters in DCNVA (Photopic) at 1 Hour and With < 5 Letters of Loss in Photopic Binocular BCDVA From Baseline | 27.93 % of subjects with improvement |
Secondary
Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline
The percentage of subjects with improvement of ≥ 5, ≥ 10, and ≥ 15 letters in DCNVA (photopic) from Baseline at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
Time frame: Visit 2 at 0.5 hours, at 2 hours, at 3 hours, at 4 hours, and at 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 0.5 hours | 88.4 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 4 hours | 46.5 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 3 hours | 46.5 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 0.5 hours | 60.5 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 4 hours | 95.3 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 4 hours | 67.4 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 2 hours | 88.4 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 0.5 hours | 76.7 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 6 hours | 67.4 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 2 hours | 81.4 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 2 hours | 62.8 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 6 hours | 88.4 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 3 hours | 95.3 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 6 hours | 37.2 percentage of subjects with improvement |
| POS 0.75% First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 3 hours | 67.4 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 3 hours | 60.0 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 4 hours | 30.0 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 2 hours | 60.0 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 3 hours | 26.7 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 0.5 hours | 50.0 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 4 hours | 60.0 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 6 hours | 86.7 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 4 hours | 83.3 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 0.5 hours | 33.3 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 3 hours | 83.3 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 6 hours | 36.7 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 6 hours | 60.0 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 2 hours | 26.7 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 2 hours | 93.3 percentage of subjects with improvement |
| POS 0.75% First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 0.5 hours | 86.7 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 3 hours | 64.5 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 0.5 hours | 74.2 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 0.5 hours | 54.8 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 0.5 hours | 25.8 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 2 hours | 83.9 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 2 hours | 71.0 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 2 hours | 41.9 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 3 hours | 83.9 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 3 hours | 48.4 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 4 hours | 83.9 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 4 hours | 51.6 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 4 hours | 32.3 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 6 hours | 71.0 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 6 hours | 54.8 percentage of subjects with improvement |
| POS Vehicle First, Then LDP 0.4% | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 6 hours | 22.6 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 3 hours | 72.7 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 0.5 hours | 52.3 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 4 hours | 20.5 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 2 hours | 18.2 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 2 hours | 45.5 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 0.5 hours | 70.5 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 6 hours | 72.7 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 2 hours | 70.5 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 0.5 hours | 15.9 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 6 hours | 18.2 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 5 letters from baseline at 4 hours | 75.0 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 15 letters from baseline at 3 hours | 20.5 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 6 hours | 50.0 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 4 hours | 50.0 percentage of subjects with improvement |
| POS Vehicle First, Then LDP Vehicle | Percentage of Subjects With Improvement of ≥ 5, ≥ 10, and ≥ 15 Letters in DCNVA (Photopic) From Baseline | % of subjects with improvement of ≥ 10 letters from baseline at 3 hours | 43.2 percentage of subjects with improvement |